MOMECOR
Each spray delivers:
Mometasone Furoate IP 50 mcg
COMPOSITION
Mometasone Furoate IP 0.05% w/v
Benzalkonium Chloride Solution BP 0.02 % v/v (as preservative)
DESCRIPTION
A white to off-white colored homogenous re-dispersible suspension.
PHARMACODYNAMIC
Pharmacotherapeutic group: Decongestants and Other Nasal Preparations for Topical Use-Corticosteroids.
ATC code: R01AD09
Mechanism of action
Mometasone furoate is a topical glucocorticosteroid with local anti-inflammatory properties at doses that are not systemically active.
It is likely that much of the mechanism for the anti-allergic and anti-inflammatory effects of mometasone furoate lies in its ability to inhibit the release of mediators of allergic reactions. Mometasone furoate significantly inhibits the release of leukotrienes from leucocytes of allergic patients. In cell culture, mometasone furoate demonstrated high potency in inhibition of synthesis and release of IL-1, IL-5, IL-6 and TNFα; it is also a potent inhibitor of leukotriene production. In addition, it is an extremely potent inhibitor of the production of the Th2 cytokines, IL-4 and IL-5, from human CD4+ T-cells.
PHARMACOKINETICS
Absorption
Mometasone furoate, administered as an aqueous nasal spray, has a systemic bioavailability of <1% in plasma, using a sensitive assay with a lower quantitation limit of 0.25 pg/ml.
Distribution
Not applicable as mometasone is poorly absorbed via the nasal route.
Biotransformation
The small amount that may be swallowed and absorbed undergoes extensive first-pass hepatic metabolism.
Elimination
Absorbed mometasone furoate is extensively metabolized and the metabolites are excreted in urine and bile.
THERAPEUTIC INDICATION
MOMECOR Nasal Spray is indicated for use in adults to treat the symptoms of seasonal or perennial allergic rhinitis symptoms in adults and pediatric patients 2 years of age and older. MOMECOR Nasal Spray is indicated for the prophylaxis of seasonal allergic rhinitis symptoms in adult and adolescent patients 12 years and older. MOMECOR is also indicated in the treatment of nasal polyps in those aged 18 and above.
DOSAGE AND ADMINISTRATION
Adults and Adolescents (>12 years)
Initially, two sprays in each nostril once daily. Prophylaxis: begin 2-4 weeks prior to anticipated start of pollen season.
Children (2-11 years)
Initially, treatment should be started with one spray in each nostril once daily.
INSTRUCTION FOR USE
Apply MOMECOR Nasal Spray in the following way:
- Shake the bottle well before using the nasal spray.
- Blow your nose gently.
- Remove the dust cap of the bottle and keep its tip between your index finger and middle finger with thumb at the bottom.
- If you are using this nasal spray for the first time or have not used it for a week or more, then examine it by spraying it, away from you in the air, few times until a fine mist appears.
- To use the spray, tilt your head forward slightly while breathing out.
- Carefully insert the nozzle tip into one of the nostrils.
- Remember to point the nozzle tip towards the corner of your eye or ear and not towards the center of your nose.
- Press down with your fingers once to release a spray.
- Pull out the nozzle tip from the nostril.
- Close the other nostril with your finger and breathe slowly through your nose and exhale slowly through mouth.
- If you have been prescribed the second dose in the same nostril, wait a minute or two and repeat the process.
- Repeat STEPS 5 through 10 for the other nostril.
- After use, wipe the nozzle with a clean handkerchief or tissue and replace the dust cap.
- Do not blow your nose for few minutes after using the spray.
- Use the nasal spray as per your doctor’s recommendation and do not exceed the dose.
CONTRAINDICATION
MOMECOR aqueous nasal spray is contradicted in patients with a hypersensitivity to any of its ingredients.
WARNING AND PRECAUTIONS
The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency. Some patients may experience symptoms of withdrawal e.g. joint and /or muscular pain, lassitude and depression.
The concomitant use of an intranasal corticosteroid with other corticosteroids could increase the risk of signs or symptoms of hypercorticoidism and/ or suppression of the HPA-axis. Therefore, MOMECOR should be used cautiously in the patient with other pathological condition requiring steroids. Intranasal corticosteroids may cause a reduction in growth velocity when administered at higher dose. The recommended dosage of MOMECOR should not be exceeded. Special care is needed in patients with lung tuberculosis and fungal and viral infection. Children who are on immunosuppressant drugs are more susceptible to infections than healthy children. Chicken pox and measles for example can have a more serious or even a fatal course in children on immunosuppressant corticosteroids.
During long-term therapy, monitoring of hematological and adrenal function is advisable.
In clinical studies with intranasal mometasone, the development of localized infections of the nose and the pharynx with candida albicans has been seen rarely. When such an infection develops, it may require treatment with appropriate local anti-infective therapy and discontinuation of the treatment with MOMECOR is advised.
PREGNANCY, LACTATION & PAEDIATRIC
Pregnancy
The use of mometasone in pregnant women requires that the therapeutic benefits of the drug be weighed against the potential hazards to the mother and the baby.
Lactation
The use of mometasone in lactating women requires that the therapeutic benefits of the drug be weighed against the potential hazards to the mother and the baby.
SIDE EFFECTS
The most commonly reported side effects are headache, pharyngitis, epistaxis, coughing and sinusitis.
If you experience any side effect, talk to your doctor or pharmacist.
PRESENTATION
MOMECOR Nasal Sprays are supplied in 10 ml polypropylene translucent nasal spray bottles containing 100 metered doses.
STORAGE AND OTHER INFORMATION
Store at temperature below 30 °C. Keep this medicine out of the sight and reach of children. Do not touch the spray tip to any surface since this may contaminate the solution.